yesterday!

With the continuous development of life sciences and the continuous improvement of drug design and clinical trials, the principle of patient-oriented clinical trials has attracted more and more attention from the academic community and regulatory authorities

On August 9, 2022, the Center for Drug Evaluation (CDE) of the State Drug Administration issued three drafts for comments, all related to "patient-centered clinical trials", namely:

"Patient-Centered Clinical Trial Design Technical Guidelines (Draft for Comment)"

"Technical Guidelines for the Implementation of Patient-Centered Clinical Trials" (Draft for Comment)

"Patient-Centered Clinical Trials Benefit-Risk Assessment Technical Guidelines (Draft for Comment)"

The guiding principles cover multiple perspectives from trial design, trial implementation to benefit-risk assessment, and can be regarded as a nanny-level tutorial for pharmaceutical R&D companies

Judging from the drafting instructions for the guiding principles, the three guiding principles have different purposes and focuses

01

Specifically, the "Technical Guidelines for Patient-Centered Clinical Trial Design" are designed to guide the design of patient-centered clinical trials, that is, to continuously understand patient needs, and combine meaningful patient experience data with scientific principles.

The paper is divided into four main chapters: Introduction, General Principles, Considerations for Patient-Centered Clinical Design, Conclusion, and References

02

The "Technical Guidelines for the Implementation of Patient-Centered Clinical Trials" is to guide the implementation of patient-centered clinical trials, that is, to implement clinical trials that are more accessible, friendly and convenient for patients

The full text is divided into five chapters, namely introduction, general principles, considerations in the implementation of clinical trials, other considerations, conclusion and references

03

"Technical Guidelines for Benefit-Risk Assessment of Patient-Centered Clinical Trials" is to guide the benefit-risk assessment of patient-centered clinical trials, incorporating patients' experiences, opinions and needs into the benefit-risk assessment of drugs in the system

The full text is mainly divided into six chapters and references.

Because they are still in the stage of soliciting opinions, pharmaceutical R&D companies still have the opportunity to communicate through the contact person and contact information published by CDE, and to communicate and discuss the problems encountered in the application process

We applaud CDE for its open and inclusive attitude, and call on pharmaceutical R&D companies to communicate with CDE in a timely manner, so that we can build a better and more complete pharmaceutical R&D ecosystem together